Skip to main content
OpenTrials
Completed

NCT Number: NCT02454400

Pre-surgery Physiotherapy for Patients With Specific Low Back Pain

The aim is to study if pre-surgery physiotherapy improves function, pain and health in patients with specific low back pain scheduled for surgery. Patients are followed over a two year period. A secondary aim is to study what factors predict short and long term outcomes.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Linköping, Östergötland County, 58183, Sweden

About this study

The design is a randomized controlled trial, where patients are allocated either to pre-surgery physiotherapy or waiting-list when scheduled for surgery due to specific low back pain (spinal stenosis, disc herniation, spondylolisthesis, disc degenerative disease (DDD)).

The patients are scheduled for surgery due to specific low back pain diagnosis and randomized to either pre-surgery physiotherapy or waiting-list group. Clinical measurement and treatment-classification is done before and after intervention.

Pre-surgery intervention:

Physiotherapy guided intervention twice a week for nine weeks. The program includes:

  • Active physiotherapy according to a treatment based classification
  • Specific exercises and mobilization
  • Motor control exercises
  • Traction
  • Tailor-made general supervised exercise program
  • Behavioral approach to reduce fear avoidance and increase activity level.

Both groups receive standardized information about surgery, post-surgery rehabilitation and to stay active.

Surgery in performed according to existing guidelines.

Measurements:

Patients fill out a questionnaire at baseline, before surgery (after pre-surgery physiotherapy or waiting-list), three months, one and two years after surgery. The questionnaire includes self-reported measures for function Oswestry Disability Index (ODI) (primary outcome), pain (VAS, pain drawing, pain duration) and health (SF-36, EQ-5D), anxiety, depression (HADS), self efficacy, fear avoidance belief questionnaire (FABQ), workability, (WAI), expectations, general information of work, sick-leave, lifestyle behavior, previous healthcare consumption, patient reported treatment effects, patient enablement instrument (PEI), and adverse events.

Clinical measurement is done before and after intervention. Clinical measurements includes; isometric quadriceps strength, walking-test, neurological tests for L4-S1, SI-joint tests, Posterior-anterior-test (PA-test), test for centralization, test for aberrant movements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients that are scheduled for surgery due to following diagnoses;

  • Disc herniation,
  • Spinal stenosis,
  • Spondylolisthesis,
  • Degenerative disc disease.
  • Fluent in Swedish.

Exclusion criteria

  • need of acute surgery
  • other severe diagnoses.

Treatment and study plan

Pre-surgery physiotherapy

Other

Physiotherapy guided intervention twice a week for nine weeks. The program includes:

  • Active physiotherapy according to a treatment based classification:
  • Specific exercises and mobilization
  • Motor control exercises
  • Traction
  • Tailor-made general supervised exercise program
  • Behavioral approach to reduce fear avoidance and increase activity level.
  • Standardized information about:
  • the surgery
  • post-surgery rehabilitation
  • to stay active

Waiting-list

Other

Standardized information about:

  • the surgery
  • post-surgery rehabilitation
  • to stay active

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

Secondary outcomes

  1. Visual analog scale for lumbar pain

    Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

    Self reported pain in lumbar and leg pain respectively

  2. Visual analog scale for leg pain

    Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

    Self reported pain in lumbar and leg pain respectively

  3. Health (SF-36, EQ-5D)

    Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

    Self reported health

  4. Anxiety, depression (HADS)

    Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

    Self reported anxiety and depression

  5. Self efficacy (SES)

    Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

    Self reported self efficacy

  6. Fear avoidance belief questionnaire (FABQ)

    Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

    Self reported fear avoidance belief questionnaire

  7. Workability, (WAI)

    Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

    Self reported workability

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Ostergotland County Council, Sweden

Registry information

Official study title

Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT

Acronym: PREPARE

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 27, 2015
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.